The following laws governed the operation of a dispensary:
- Pharmacy and Poisons Ordinance Cap.138
- Antibiotics Ordinance Cap.137
- Dangerous Drugs Ordinance Cap.134
- Undesirable Medical Advertisements Ordinance Cap.231
- Public Health and Municipal Services Ordinance Cap.132
- Chinese Medicine Ordinance Cap.549
- Trade Descriptions Ordinance Cap.362
- Control of Chemicals Ordinance Cap.145
- Protection of Endangered Species of Animals and Plants Ordinance Cap.586
- Business Registration Ordinance Cap.310
- The Companies Ordinance Cap.32
- Waste Disposal Ordinance Cap.354
- Employees’ Compensation Ordinance Cap.282
- Mandatory Provident Fund Schemes Ordinance Cap.485
- Pesticides Ordinance Cap.133, … etc.
The following figure showed the type of companies and its legal person.
Authorized Seller of Poisons (ASP) (獲授權毒藥銷售商 – 俗稱 “藥房牌”)
- A business comprising the retail sale of poisons carried on by a registered pharmacist or by a body corporate or an unincorporated body of persons shall be an ASP if the actual sale of poisons is conducted on premises duly registered under the Pharmacy and Poisons Ordinance by a registered pharmacist or in his presence and under his supervision.
Licensing Conditions in Form 16 are shown as follows:
i) ASP shall produce his certificate of registration of premises for inspection.
ii) The receipt of Part I Poisons or Antibiotics shall be attended to and signed by the registered pharmacist.
iii) PIS1 Poisons & Antibiotics shall be kept in a locked receptacle, the key to which shall be kept only by the registered pharmacist.
iv) Record of transactions involving Psychotropic Substances shall be maintained.
- An ASP may display at the premises, where the retail sale of poisons is conducted, a logo in the prescribed form in the Eighth Schedule (Form 17).
Listed Seller of Poisons (LSP) (列載毒藥銷售商 – 俗稱 “藥行牌”)
- The Pharmacy and Poisons Board (the Board) shall keep a list of persons who, not being ASP, to be entitles to conduct the retail sale of a class or classes of poisons included in Part II of the Poisons List.
- The Pharmacy and Poisons Board (the Board) shall keep a list of persons who, not being ASP, to be entitles to conduct the retail sale of a class or classes of poisons included in Part II of the Poisons List.
Example of LSP: medicine company (e.g. Waston’s & Mannings), Supermarket (e.g. Park’N, Wellcome), Department store (e.g. Sogo, Wing On), Convenience store (e.g. 7-Eleven, Circle K), Cosmetic company (e.g. Sa Sa), and Household shop (e.g. Jusco $10 Plaza).
Import / Export Control of Pharmaceutical Products were governed by the following laws:- Import and Export Ordinance Cap.60
- Dangerous Drugs Ordinance Cap.134
- Antibiotics Ordinance Cap.137
- Pharmacy and Poisons Ordinance Cap.138
Under the Import and Export Ordinance Cap.60 of the Laws of Hong Kong, all imports and exports of pharmaceutical products and medicines (includes dangerous drugs) must be covered by a relevant and valid import/export license that is issued by the Director-General of Trade and Industry.
The following requirements showed the application of Import License.
- Import License Form 3 (blue) together with the following relevant license/permit or combination for the appropriate application:
i) Certificate of Registration as an Importer and Exporter of Pharmaceutical Products (Form 14)
ii) Wholesale Poisons License (Form 1)
iii) License for Manufacturer
iv) Antibiotic Permit
v) Certificate for Registration of Premises
The following requirements showed the application of Export License.
- Export License Form 6 (white) together with the following relevant license/permit or combination for the appropriate application:
i) Certificate of Registration as an Importer and Exporter of Pharmaceutical Products (Form 14)
ii) Wholesale Poisons License (Form 1)
iii) License for Manufacturer
iv) Antibiotic Permit
v) Certificate for Registration of Premises
For Dangerous Drugs (D.D.), including non-pharmaceutical products, it required:
- Wholesale Dealer’s License to Supply Dangerous Drugs
- License to Manufacture Preparations of Dangerous Drugs
Application for Import License Additional Requirements
- The product is registered in Hong Kong – Certificate of Drug/Product Registration (Form 7)
- For Clinical Trial – Certificate of Clinical Trial / Medicinal Test
Exceptions:
- Pharmaceutical raw material imported by manufacturer for own manufacturing
- Import for re-export
- Sample (reasonable quantity) for registration purpose or clinical trial application
- For treatment of named patient(s) or particular animal(s)
For importing D.D. (Psychotropic), international matching was required.
The following figure showed the procedure of dangerous drug import and export.
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